BIOTHERM— 510(k) K833839

Substantially Equivalent

Trileen, Inc.

FDA 510(k) clearance K833839 for BIOTHERM, Substantially Equivalent on 1983-12-27. Applicant: Trileen, Inc..

Clearance details

Applicant: Trileen, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1983-11-03
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.